BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO CF REFLUX CAPSULE DELIVERY

    MDR report key: 23497524 · Received November 7, 2025

    Report

    Report Number
    MW5178617
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 31, 2025
    Manufacturer
    GIVEN IMAGING INC. / GIVEN IMAGING LTD.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BRAVO LOT # 66652F ID# (B)(6) PROTOCOL FOLLOWED FOR CAPSULE PLACEMENT. CAPSULE FAILED TO PROPERLY ATTACH. THE SURGEON, ANESTHESIOLOGIST, NP (NURSE PRACTITIONER), AND NURSES ALL WORKED TOGETHER VERY QUICKLY AND CALMLY TO RETRIEVE THE CAPSULE TO PREVENT IT FROM ENTERING THE AIRWAY. THIS ATTACHMENT FAILURE HAS BEEN REPORTED TO MEDTRONIC TECH SUPPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/12/2025 FOR REPORT MW5178617 TO UPDATE PROCODE TO FFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186146 BRAVO CF REFLUX CAPSULE DELIVERY ELECTRODE, PH, STOMACH FFT GIVEN IMAGING INC. / GIVEN IMAGING LTD. 66652F

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention